CREST EXPRESSIONS SCOPE- sodium fluoride paste, dentifrice 
Teresa Cecena DBA Genesis Imports

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ACTIVE INGREDIENT

Sodium Fluoride

PURPOSE

Anticavity toothpaste

WARNINGS

kEEP OUT OF REACH OF CHILDREN UNDER 6 YRS OF AGE.IF MORE THAT USED FOR BRUSHING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL VENTER RIGHT AWAY.

DIRECTIONS

to minimize swallowing use a pea-sized amount in children under 6

supervise children's brushing until good habits are established

sorbitol,water,hydrated silica,disodium pyrophosphate, sodium lauryl sulfate, flavor, sodium hydroxide, alcohol, xanthan gum, sodium saccharin , glycerin, carbomer, cellulose gum, polysorbate 80, sodium benzoate, cethylpyridinium chloride, benzoic acid, titanium dioxide, blue 1, yellow 5

QUESTIONS?

1-800-492-7378

KEEP OUT OF REACH OF CHILDREN UNDER 6 YEARS

DIRECTION

Adults and childreen 2 yrs and older ; brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist

CREST EXPRESSIONS

CREST EXPRESSIONS SCOPE 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69772-820
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION243 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
ALCOHOL (UNII: 3K9958V90M)  
Product Characteristics
ColorgreenScore    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69772-820-01100 g in 1 TUBE; Type 0: Not a Combination Product01/28/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/28/2016
Labeler - Teresa Cecena DBA Genesis Imports (078760958)
Registrant - Teresa Cecena (078760958)
Establishment
NameAddressID/FEIBusiness Operations
Teresa Cecena DBA Genesis078760958relabel(69772-820)
Establishment
NameAddressID/FEIBusiness Operations
procter & gamble manufactura s. de r.l. de cv812807550manufacture(69772-820)

Revised: 1/2016
Document Id: 2a6bf243-b168-484d-e054-00144ff8d46c
Set id: 2a6bf243-b167-484d-e054-00144ff8d46c
Version: 1
Effective Time: 20160128
 
Teresa Cecena DBA Genesis Imports